(48 days)
No
The description details standard image processing techniques and hardware components for digital radiography. There is no mention of AI, ML, or related concepts. The "Intelligent-Grid" is mentioned as cleared in a previous K number, suggesting it's a pre-existing, likely non-AI/ML feature.
No
The device is described as generating radiographic images for diagnostic procedures, which is an imaging function, not a therapeutic one.
Yes
Explanation: The device is indicated for use in "general-purpose diagnostic procedures" and outputs "diagnostic image data."
No
The device description explicitly mentions hardware components like an "X-ray planar detector" and "flat-panel x-ray detectors (FPDs)". While it includes image processing software, it is an integral part of a larger hardware system for generating radiographic images.
Based on the provided information, the SKR 3000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "generating radiographic images of human anatomy" for "general-purpose diagnostic procedures." This involves imaging the internal structures of the body using X-rays.
- Device Description: The device description details how it captures X-ray images using a planar detector and processes them for display and storage. This is consistent with medical imaging equipment, not devices that analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The SKR 3000 is a medical imaging device that produces images of the body itself.
N/A
Intended Use / Indications for Use
The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures.
The SKR 3000 is not indicated for use in mammography, fluoroscopy and angiography applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB, LLZ
Device Description
The digital radiography SKR 3000 performs X-ray imaging of the human body using an Xray planar detector that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data.
- This device is not intended for use in mammography
- This device is also used for carrying out exposures on children.
The Console CS-7, which controls the receiving, processing, and output of image data, is required for operation. CS-7 implements the following image processing; gradation processing, frequency processing, dynamic range compression, smoothing, rotation, reversing, zooming, and grid removal process/scattered radiation - correction (Intelligent-Grid). The Intelligent-Grid is cleared in K151465.
This submission is to add new flat-panel x-ray detectors (FPDs), P-82 and P-85, into the SKR 3000. The P-82 and P-85 employ the same surface material infused with Silver ions (antibacterial properties) as the predicate device. The only difference between the P-82 and P-85 is the number of Li-ion capacitors. The P-85 has two Li-ion capacitors and the P-82 has one. These new P-82 and P-85 are not applicable to the serial radiography which acquires multiple frames of radiography image serially.
The FPDs used in SKR 3000 can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.
The SKR 3000 is distributed under a commercial name AeroDR 3.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found (The device is also used for carrying out exposures on children, but no specific age range is provided.)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SKR 3000 is designed to comply with the following standard; AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2 (Ed.4.0), and ISO 10993-1 (2018). The performance tests according to the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and the other verification and validation including the items required by the risk analysis for the SKR 3000 were performed and the results demonstrated that the predetermined acceptance criteria were met. The results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
January 31, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Konica Minolta, Inc. % Jan Maniscalco Director of QA/RA Konica Minolta Healthcare Americas, Inc. 411 Newark-Pompton Turnpike WAYNE NJ 07470
Re: K213908
Trade/Device Name: SKR 3000 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, LLZ Dated: December 10, 2021 Received: December 14, 2021
Dear Jan Maniscalco:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk Assistant Director Diagnostic X-ray Systems Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213908
Device Name SKR 3000
Indications for Use (Describe)
The SKR 3000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpose diagnostic procedures.
The SKR 3000 is not indicated for use in mammography, fluoroscopy and angiography applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image contains the Konica Minolta logo. The logo consists of a blue sphere with several horizontal white lines across it. Below the sphere, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
510(k) Summary K213908
| Company: | KONICA MINOLTA, INC.
1 Sakura-machi, Hino-shi, Tokyo, 191-8511, Japan |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tsutomu Fukui
Senior Manager of Regulatory & QMS Division
Quality Assurance Operations, Healthcare Business Unit
Telephone: +81 42 589 8429
Email: tsutomu.fukui1@konicaminolta.com |
| Date Prepared: | January 24, 2022 |
| Device Name: | SKR 3000 |
| Common Name: | Digital Radiography |
| Regulation Number: | 21 CFR 892.1680 |
| Regulation Name: | Stationary x-ray system |
| Regulatory Class: | Class II |
| Product Code(s): | MQB, LLZ |
| Predicate Device: | K210619 - SKR 3000 (KONICA MINOLTA, INC.)
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary x-ray system
Regulatory Class: Class II
Product Codes: MQB, LLZ |
Device Description
The digital radiography SKR 3000 performs X-ray imaging of the human body using an Xray planar detector that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data.
-
This device is not intended for use in mammography
-
This device is also used for carrying out exposures on children.
-
Page 1 of 4 -
4
Image /page/4/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a blue circle at the top with several white horizontal lines running across it. Below the circle is the text "KONICA MINOLTA" in a bold, sans-serif font.
The Console CS-7, which controls the receiving, processing, and output of image data, is required for operation. CS-7 implements the following image processing; gradation processing, frequency processing, dynamic range compression, smoothing, rotation, reversing, zooming, and grid removal process/scattered radiation - correction (Intelligent-Grid). The Intelligent-Grid is cleared in K151465.
This submission is to add new flat-panel x-ray detectors (FPDs), P-82 and P-85, into the SKR 3000. The P-82 and P-85 employ the same surface material infused with Silver ions (antibacterial properties) as the predicate device. The only difference between the P-82 and P-85 is the number of Li-ion capacitors. The P-85 has two Li-ion capacitors and the P-82 has one. These new P-82 and P-85 are not applicable to the serial radiography which acquires multiple frames of radiography image serially.
The FPDs used in SKR 3000 can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.
The SKR 3000 is distributed under a commercial name AeroDR 3.
Indications for Use
This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, fluoroscopy, and angiography applications.
Comparison Table
The comparison to the predicate device was summarized in the table blow.
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | SKR 3000 | SKR 3000 |
| 510(K) Number | K213908 | K210619 |
| Indications for Use | This device is indicated for use in | |
| generating radiographic images of | ||
| human anatomy. It is intended to a | ||
| replace radiographic film/screen | This device is indicated for use in | |
| generating radiographic images of | ||
| human anatomy. It is intended to a | ||
| replace radiographic film/screen | ||
| Subject Device | Predicate Device | |
| system in general-purpose diagnostic | ||
| procedures. | ||
| This device is not indicated for use in | ||
| mammography, fluoroscopy, and | ||
| angiography applications. | system in general-purpose diagnostic | |
| procedures. | ||
| This device is not indicated for use in | ||
| mammography, fluoroscopy, and | ||
| angiography applications. | ||
| Specification | ||
| Detection method | ||
| Scintillator | ||
| TFT sensor substrate | ||
| Image area size | Indirect conversion method | |
| Csl (Cesium Iodide) | ||
| Film-based TFT substrate | ||
| P-82: 348.8×425.6mm | ||
| (3,488×4,256 pixels) | ||
| P-85: 348.8×425.6mm | ||
| (3,488×4,256 pixels) | Indirect conversion method | |
| Csl (Cesium Iodide) | ||
| Glass-based TFT substrate | ||
| P-65: 348.8×425.6mm | ||
| (3,488×4,256 pixels) | ||
| Pixel size | 100 μm / 200 μm | 100 μm / 200 μm / 400 μm |
| A/D conversion | 16 bit (65,536 gradients) | 16 bit (65,536 gradients) |
| Max. Resolution | P-82: 4.0 lp/mm | |
| P-85: 4.0 lp/mm | P-65: 4.0 lp/mm | |
| MTF (1.0 lp/mm) | (Non-binning) 0.62 | |
| (2x2 binning) 0.58 | (Non-binning) 0.62 | |
| (2x2 binning) 0.58 | ||
| DQE (1.0 lp/mm) | 59% @ 1mR | 56% @ 1mR |
| Mechanical | ||
| External dimensions | P-82: 384(W)×460(D)×15(H)mm | |
| P-85: 384(W)×460(D)×15(H)mm | P-65: 384(W)×460(D)×15(H)mm | |
| IP Code (IEC 60529) | IP56 | IPX6 |
| Battery | ||
| Type | ||
| Number of batteries | ||
| Battery duration in | ||
| standby status | Lithium-ion capacitor | |
| P-82: One | ||
| P-85: Two | ||
| P-82: Approx. 6.0 hours | ||
| P-85: Approx. 13.2 hours | Lithium-ion capacitor | |
| P-65: Two | ||
| P-65: Approx. 13.2 hours | ||
| Surface Material | Surface infused with Silver ions | |
| (antibacterial properties) | Surface infused with Silver ions | |
| (antibacterial properties) | ||
| Communication I/F | Wired and Wireless | Wired and Wireless |
| Peripherals, | ||
| Cables/minor | ||
| components | AeroDR Interface Units, Detector | |
| Interface Units, Power Supply Unit, | ||
| Generator Interface Units, Battery | AeroDR Interface Units, Detector | |
| Interface Units, Power Supply Unit, | ||
| Generator Interface Units, Battery | ||
| Subject Device | Predicate Device | |
| Charger, etc. | Charger, etc. | |
| Operator console | ||
| (Software) | CS-7 |
- AeroDR3 interface for P-82 and P-85
(CTDS) | CS-7 - AeroDR3 interface for P-65 (CTDS) |
| Image Processing | Auto-gradation process
Frequency processing (F process)
Equalization processing (E process)
Hybrid processing (HF process - HE
process)
Hybrid smoothing process (HS process)
REALISM processing (RE process - RF
process)
Realism smoothing process (RS
process)
Grid removal process/Scattered
Radiation Correction (Intelligent-Grid)
Automatic exposure field recognition
process | Auto-gradation process
Frequency processing (F process)
Equalization processing (E process)
Hybrid processing (HF process - HE
process)
Hybrid smoothing process (HS process)
REALISM processing (RE process - RF
process)
Realism smoothing process (RS
process)
Grid removal process/Scattered
Radiation Correction (Intelligent-Grid)
Automatic exposure field recognition
process |
| Serial radiography | Not applicable | Applicable |
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Giving Shape to Ideas
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Image /page/5/Picture/0 description: The image contains the logo for Konica Minolta. The logo features a blue circle with several horizontal white lines running across it. Below the circle, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
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Image /page/6/Picture/0 description: The image contains the logo for Konica Minolta. The logo features a blue circular emblem at the top with several horizontal white lines running across it. Below the emblem, the words "KONICA MINOLTA" are written in a bold, sans-serif font.
Performance Data
The SKR 3000 is designed to comply with the following standard; AAMI/ANSI ES 60601-1 (Ed.3.1), IEC 60601-1-2 (Ed.4.0), and ISO 10993-1 (2018). The performance tests according to the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and the other verification and validation including the items required by the risk analysis for the SKR 3000 were performed and the results demonstrated that the predetermined acceptance criteria were met. The results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device.
Conclusion
The SKR 3000 has the same intended use and indications for use, technological characteristics, and principal operations. The technological differences raised no new issues of safety or effectiveness as compared to its predicate device (K210619). Performance tests demonstrate that the SKR 3000 performs according to specifications and functions as intended. All the information to demonstrate assurance of our evaluation is attached to relevant sections of this submission.
Therefore, as for our conclusion, the SKR 3000 is substantially equivalent to the predicate devices and presents no new questions of safety or effectiveness.
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Giving Shape to Ideas